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SICD SYSTEM - Q-TECH PROGRAMMER (2017-07-04)
- Starting date:
- July 4, 2017
- Posting date:
- November 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65154
Affected products
SICD SYSTEM - Q-TECH PROGRAMMER
Reason
Observations indicate that this device delivered an atypical amount of energy likely contributing to patient death. The most likely cause was a transient corruption of the S-ICD operating state or device memory due to a Single Event Upset (SEU). SEU's are known to affect memory in electronic devices and high reliability devices (pacemakers or defibrillators) include mechanisms to deal with this issue to reduce the occurrence of potentially harmful malfunctions.
Affected products
SICD SYSTEM - Q-TECH PROGRAMMER
Lot or serial number
All lots
Model or catalog number
3200
Companies
- Manufacturer
-
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES